Browsing Tag
US Food and Drug Administration
348 posts
Natco Pharma gets FDA approval for Lenalidomide Capsules
Natco Pharma has secured the final approval from the US Food and Drug Administration (FDA) of its abbreviated…
Unichem Laboratories gets FDA approval for Amitriptyline HCl Tablets generic
Unichem Laboratories, an Indian specialty pharma company, said that it has secured abbreviated new drug application (ANDA) approval…
Can Alembic Pharmaceuticals challenge Latuda with its FDA-approved Lurasidone Hydrochloride Tablets?
Find out how Alembic Pharmaceuticals’ FDA approval for Lurasidone Hydrochloride Tablets positions the drugmaker in the $3.7B bipolar depression market.
Transcenta gets US FDA clearance for launching phase 1 trial of TST005
Transcenta has secured clearance of its investigational new drug (IND) application for TST005 from the US Food and Drug…
BMS, bluebird bio bag Abecma FDA approval for multiple myeloma in adults
Abecma FDA approval : Bristol Myers Squibb (BMS) and bluebird bio have secured approval from the US Food…
FDA accepts Airway’s IND for AT-100 for bronchopulmonary dysplasia treatment in preterm infants
Bronchopulmonary dysplasia treatment : Airway Therapeutics said that the US Food and Drug Administration (FDA) has accepted its…
Anixa Biosciences files IND with FDA for ovarian cancer CAR-T therapy
Anixa Biosciences said that it has filed an investigational new drug (IND) application for its ovarian cancer CAR-T…
Precigen gets FDA orphan drug status for PRGN-2012 in RRP
Precigen has secured orphan drug designation (ODD) for PRGN-2012 from the US Food and Drug Administration (FDA) in…
Cytocom gets FDA nod for phase 2 trial of Covid drug candidate CYTO-205
Cytocom has secured clearance from the US Food and Drug Administration (FDA) to undertake a phase 2 clinical…
J&J Ad26.COV2.S COVID-19 vaccine gets FDA emergency use authorization
Johnson & Johnson (J&J) said that the US Food and Drug Administration (FDA) has given emergency use authorization…